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A study in healthy male subjects to investigate whether administration of ACT-541468 can affect the fate in the body (amount and time of presence in the blood) of rosuvastatin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | Rosuvastatin Day 1 |
|
| Treatment B1 | Experimental | ACT-541468 Day 5 to Day 7 |
|
| Treatment B2 | Other | Rosuvastatin Day 8; ACT-541468 Day 8 to Day 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 10 mg tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin | Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin | During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. |
| Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin | Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin | During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. |
| Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin | Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin | During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. |
| Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin | Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin | During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. |
| Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin | Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin | During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Trough concentration (Ctrough) of ACT-541468 | Trough concentration (Ctrough) of ACT-541468 | During ACT-541468 administration (Treatment B1 and B2); i.e. for about 1 week |
| Change in vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemens Mühlan | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cepha s.r.o. | Pilsen | 32300 | Czechia |
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| ACT-541468 |
| Drug |
25 mg hard capsule |
|
Change from baseline to each time point of measurement during each treatment in vital signs (supine BP and pulse rate)
| From Screening to EOS (for a maximum of up to 5 weeks) |
| Change in ECG variables | Change from baseline to each time point of measurement during each treatment in ECG variables | From Screening to EOS (for a maximum of up to 5 weeks) |
| Treatment-emergent (serious) adverse events | Treatment-emergent AEs and SAEs during each treatment | From Screening to EOS (for a maximum of up to 5 weeks) |
| Treatment-emergent ECG abnormalities | Treatment-emergent ECG abnormalities during each treatment | From Screening to EOS (for a maximum of up to 5 weeks) |
| Change in body weight | Change from baseline to each time point of measurement during each treatment in body weight | From Screening to EOS (for a maximum of up to 5 weeks) |
| Change in clinical laboratory tests | Change from baseline to each time point of measurement during each treatment in clinical laboratory tests | From Screening to EOS (for a maximum of up to 5 weeks) |
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| C000634383 | daridorexant |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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